Prescription medicine
Ertugliflozin and metformin Brand names: Segluromet
Ertugliflozin and metformin (Segluromet) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $5.76 per Segluromet 2.5-1,000 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the ertugliflozin and metformin FDA label on DailyMed (effective August 11, 2026, Merck Sharp & Dohme LLC); the NDA 209806 record on Drugs@FDA; every ertugliflozin and metformin label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1) ]. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6 , 8.7 )]. […]
Used for
From the label: indications and usageSEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 2.5 mg / 500 mg
- 2.5 mg / 1000 mg
- 7.5 mg / 1000 mg
- 7.5 mg / 500 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2017 Segluromet, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 19, 2031 Segluromet tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $5.76 per tablet Segluromet 2.5-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 82 through July 30, 2026
What is ertugliflozin and metformin used for?
From the label: indications and usageSEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ].
Conditions named in the indications of ertugliflozin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide.
Source: FDA drug label (SEGLUROMET), Merck Sharp & Dohme LLC, effective August 11, 2026 (SPL set a6aeb99a-ce49-4125-90ce-642df3f1ebad), via openFDA; the full label on DailyMed
What does the patient leaflet for ertugliflozin and metformin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SEGLUROMET?SEGLUROMET may cause serious side effects, including: Lactic Acidosis. Metformin, one of the medicines in SEGLUROMET, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis: you feel cold in your hands or feet you feel very weak or tired you have trouble breathing you have stomach pains, nausea or vomiting you have a slow or irregular heartbeat you have unusual (not normal) muscle pain you have unusual sleepiness or sleep longer than usual you feel dizzy or lightheaded Most people who have had lactic acidosis had other conditions that, in combination with metformin use, led to the lactic acidosis. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting. […]
From the patient leaflet: What should I avoid while taking SEGLUROMET?Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store SEGLUROMET?Store SEGLUROMET at room temperature between 68°F to 77°F (20°C to 25°C). Keep SEGLUROMET dry. Keep SEGLUROMET and all medicines out of the reach of children.
Source: FDA drug label (SEGLUROMET), Merck Sharp & Dohme LLC, effective August 11, 2026 (SPL set a6aeb99a-ce49-4125-90ce-642df3f1ebad), via openFDA; the full label on DailyMed
Is there a generic for ertugliflozin and metformin (Segluromet)?
No generic ertugliflozin and metformin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Segluromet tablets: the compound patent runs to December 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ertugliflozin and metformin (Segluromet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.76 per Segluromet 2.5-1,000 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Segluromet 2.5-500 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Segluromet 2.5-1,000 mg tablet | Brand | $5.76 per tablet | $172.66 | +0.3% |
| Segluromet 2.5-500 mg tablet | Brand | $5.70 per tablet | $171.04 | +0.1% |
| Segluromet 7.5-1,000 mg tablet | Brand | $5.71 per tablet | $171.35 | -0.1% |
| Segluromet 7.5-500 mg tablet | Brand | $5.74 per tablet | $172.09 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ertugliflozin and metformin label say about other medicines?
The ertugliflozin and metformin label names 11 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of Topiramate or other carbonic anhydrase inhibitors (…) with metformin. These drugs frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic … Intervention: more frequent monitoring of these patients. |
| Cimetidine | drug interactions | … [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) which increase systemic exposure to metformin |
| Dichlorphenamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of Topiramate or other carbonic anhydrase inhibitors (…) with metformin. These drugs frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic … Intervention: more frequent monitoring of these patients. |
| Dolutegravir | drug interactions | … cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) which increase systemic exposure to metformin |
| Isoniazid | drug interactions | Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin … Intervention: When a patient is receiving SEGLUROMET along with such drugs, the patient should be closely observed to maintain adequate glycemic control. |
| Lithium | drug interactions | Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during SEGLUROMET initiation and dosage changes. |
| Phenytoin | drug interactions | Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin … Intervention: When a patient is receiving SEGLUROMET along with such drugs, the patient should be closely observed to maintain adequate glycemic control. |
| Ranolazine | drug interactions | … metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) which increase systemic exposure to metformin |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart … |
| Vandetanib | drug interactions | … organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) which increase systemic exposure to metformin |
| Zonisamide | drug interactions | Carbonic Anhydrase Inhibitors Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of Topiramate or other carbonic anhydrase inhibitors (…) with metformin. These drugs frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic … Intervention: more frequent monitoring of these patients. |
Source: FDA drug label (SEGLUROMET), Merck Sharp & Dohme LLC, effective August 11, 2026 (SPL set a6aeb99a-ce49-4125-90ce-642df3f1ebad), via openFDA; the full label on DailyMed
What do FAERS reports show for ertugliflozin and metformin?
The FDA Adverse Event Reporting System holds 82 reports that list ertugliflozin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 16 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ertugliflozin and metformin?
19 other medicines are given the same way (oral) and in the same FDA class as ertugliflozin and metformin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| Repaglinide | Type 2 diabetes | 7 labelers | $0.0987 per tablet 1 mg tablet | No current entry |
| Nateglinide | Type 2 diabetes | 9 labelers | $0.179 per tablet 60 mg tablet | No current entry |
| Acarbose | Type 2 diabetes | 6 labelers | $0.274 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as ertugliflozin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ertugliflozin and metformin
- 19 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Ertugliflozin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other